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OpenTrials
Completed

NCT Number: NCT05019950

Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.

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Key information

Conditions

Normal Healthy Volunteers

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Herston, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
  • Adult males and females, 18 to 64 years of age (inclusive) at screening;
  • Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Key Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
  • Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
  • COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.

Treatment and study plan

NIM-1324

Drug

Once daily oral tablet

Placebo

Drug

Once daily oral tablet

Primary outcomes

  1. Safety and Tolerability

    Time frame: 1 to 14 days

Secondary outcomes

  1. PK

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

NImmune Biopharma

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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